NavitsPartners
USITLSP - Lead Statistical Programmer
NavitsPartners, Denver, Colorado, United States, 80285
Job Title : Lead Statistical Programmer
Reports to : Head of Statistical Programming
Job Purpose
Responsible for overseeing the timely, quality-driven, and cost-efficient execution of all statistical programming aspects for assigned studies or project-level activities. Acts as the primary liaison between statistical programming and other clinical trial team members.
Key Responsibilities Lead statistical programming activities for studies, including requirements analysis, resource estimation, planning, tracking, and development. Develop and review dataset specifications to ensure accuracy and compliance. Coordinate and oversee the work of programming teams, facilitating kickoff meetings and defining roles, responsibilities, timelines, and standards. Remove barriers to timely and high-quality deliverables and ensure programmers have the necessary resources. Provide solutions to programming challenges and ensure their efficient implementation. Maintain effective communication with clinical teams, reporting status, risks, and mitigation strategies. Contribute to the development of standards, processes, and knowledge-sharing initiatives. Ensure all deliverables meet audit and quality control standards and that statistical analysis outputs are accurate and reliable. Key Performance Indicators
Timeliness and quality of statistical programming deliverables. Effectiveness in leading and coordinating teams. Strong communication and collaboration within clinical trial teams. Compliance with internal and regulatory standards, as measured by audit outcomes. Ability to work with minimal supervision while maintaining high-quality outcomes. Impact on Organization
High-quality statistical programming deliverables that support timely product submissions, reducing potential project delays and financial risks. Efficient programming leading to faster development and registration processes. Maintaining the organization's positive reputation with regulatory authorities through high-quality submissions. Competency Profile
Advanced SAS programming skills, including macro development. Strong experience in resource planning, deliverable tracking, and team coordination. Proficiency in developing dataset specifications. Solid understanding of statistical concepts and regulatory guidelines (e.g., GCP, ICH) and industry standards such as CDISC. Excellent communication and team collaboration skills. Language Requirement
Fluency in English (reading, writing, speaking).
Education
Bachelor's, Master's, or equivalent degree in mathematics, statistics, computer science, health sciences, or a related field.
Minimum Requirements
At least 5 years of relevant programming experience. Minimum 2 years of experience leading statistical programming activities. Preferred Requirements
Relevant experience in the pharmaceutical or medical device industry.
Reports to : Head of Statistical Programming
Job Purpose
Responsible for overseeing the timely, quality-driven, and cost-efficient execution of all statistical programming aspects for assigned studies or project-level activities. Acts as the primary liaison between statistical programming and other clinical trial team members.
Key Responsibilities Lead statistical programming activities for studies, including requirements analysis, resource estimation, planning, tracking, and development. Develop and review dataset specifications to ensure accuracy and compliance. Coordinate and oversee the work of programming teams, facilitating kickoff meetings and defining roles, responsibilities, timelines, and standards. Remove barriers to timely and high-quality deliverables and ensure programmers have the necessary resources. Provide solutions to programming challenges and ensure their efficient implementation. Maintain effective communication with clinical teams, reporting status, risks, and mitigation strategies. Contribute to the development of standards, processes, and knowledge-sharing initiatives. Ensure all deliverables meet audit and quality control standards and that statistical analysis outputs are accurate and reliable. Key Performance Indicators
Timeliness and quality of statistical programming deliverables. Effectiveness in leading and coordinating teams. Strong communication and collaboration within clinical trial teams. Compliance with internal and regulatory standards, as measured by audit outcomes. Ability to work with minimal supervision while maintaining high-quality outcomes. Impact on Organization
High-quality statistical programming deliverables that support timely product submissions, reducing potential project delays and financial risks. Efficient programming leading to faster development and registration processes. Maintaining the organization's positive reputation with regulatory authorities through high-quality submissions. Competency Profile
Advanced SAS programming skills, including macro development. Strong experience in resource planning, deliverable tracking, and team coordination. Proficiency in developing dataset specifications. Solid understanding of statistical concepts and regulatory guidelines (e.g., GCP, ICH) and industry standards such as CDISC. Excellent communication and team collaboration skills. Language Requirement
Fluency in English (reading, writing, speaking).
Education
Bachelor's, Master's, or equivalent degree in mathematics, statistics, computer science, health sciences, or a related field.
Minimum Requirements
At least 5 years of relevant programming experience. Minimum 2 years of experience leading statistical programming activities. Preferred Requirements
Relevant experience in the pharmaceutical or medical device industry.